Portable RFID tagged carrier for sterile implants and biological products

ABSTRACT

Intelligent portable carrier device for supporting movement in product tracking and monitoring of regulated products, such as tissue and biologics. Embodiments of the invention use product identification technology, such as radio-frequency identification (RFID) tags and readers, to uniquely identify the regulated products as they are added to or removed from the intelligent portable carrier device. Embodiments of the invention may also be configured to monitor and report temperature and other environmental conditions associated with the intelligent portable carrier device.

BACKGROUND

1. Field of the Invention

The present invention relates to a monitoring system and method, andmore particularly, to systems and methods to support improvements inproduct tracking and monitoring of regulated products such as sterileimplants and biological products.

2. Description of the Related Art

In the realm of transporting regulated products such as tissue andbiologics, there is a need to track the objects as they are removed froman existing back-end inventory tracking system. One method of trackingthe objects while in transport is by using radio frequencyidentification devices (RFIDS), which are known in the art. Such devicesare typically used for inventory tracking.

As regulated products such as sterile implants and biological productsare moved in inventory, product manufacturing, and merchandisingoperations, there is a continuous challenge to accurately track andmonitor the location and flow of objects, including temperature,humidity, pH, etc. Additionally, there is a continuing goal to determinethe location of objects and the environmental conditions of the productsin an inexpensive and streamlined manner.

When regulated products are moved by sales representatives and taken tospecific locations, monitoring and tracking of these products will end.Product regulation resumes only when the products are brought back toSmart Storage Sites.

Therefore, what is needed in the art is a system and method for storing,tracking, and transporting stored sensitive regulated products such assterile implants and other biologic products that overcome the abovedrawbacks. This would provide real-time inventory and criticalmonitoring data such as temperature during transport.

SUMMARY

The invention, in various embodiments, addresses deficiencies in theprior art by providing an intelligent portable carrier device, forexample a container, that supports movement in product tracking andmonitoring of regulated products, such as tissue and biologics. Thepresent invention uses product identification technology, such asradio-frequency identification (RFID) tags and readers to uniquelyidentify the regulated products as they are added to or removed from theintelligent portable carrier device. A primary, but not exclusivepurpose of the intelligent portable carrier device is as a temporarystorage process for transportation purposes of sterile and non-sterilemedical implants, biologic products, or other RFID enabled materialsthat require continuous monitoring during transportation.

In various embodiments, the intelligent portable carrier device isprovided with a closable opening designed to inventory temporarilystored sensitive items, such as biological materials, provide criticalmonitoring data, such as temperature monitoring, as well as communicateglobal positioning system (GPS) location and provide a furthercapability to transmit the critical monitoring data wirelessly in realtime to an existing back-end inventory tracking system using knownwireless methods.

A system for monitoring a carrier with a closable opening may comprise:an RFID device; one or more processors configured to monitor and managecertain events related to the temporarily stored sensitive items; amemory for storing monitored data; at least one sensor module; atransmitter for transmitting messages over a wireless network, themessages including modulated information received from the RFID deviceand the one or more monitoring sensors; a receiving device comprising areceiver for receiving messages transmitted by the RFID device andmessages received over the wireless network. At least the informationrelating to one or more stored sensitive items or conditions sensed bythe one or more sensors are processed for providing an indication of thecondition of the one or more stored sensitive items.

The event monitoring and event managing processor(s) may be embodied,for example, in one or more software application programs, routines ormodules configured to be executed by a general purpose microprocessor,in one or more hardware devices, such as a programmable logic controller(PLC), in one or more firmware devices, or in some combination ofsoftware application programs, hardware and/or firmware devices.Typically, although not necessarily, the event monitoring processor(hereinafter referred to as the event monitor) is configured to monitorand detect new events associated with pharmaceutical product containersplaced in or near the refrigerator, as well as to monitor and detect newevents associated with the refrigerator itself. In some embodiments, theevent monitor will generate event codes indicating what type of eventhas occurred. The event managing processor (hereinafter referred to asthe event manager) typically carries out a series of instructions thatare appropriate for the particular event that has just occurred.Notably, alternative embodiments of the invention may use fewer or morePLCs, computer software programs, and modules or routines to perform thesame functions as the event monitor and event manager. In someembodiments, for example, the functions of the event monitor and theevent manager may be performed by the same hardware or softwareprocessor.

The intelligent portable carrier device can include common computing andcommunication technology (such as a microprocessor, digital signalprocessor, GSM, CDMA and/or WiFi transceiver and so forth) for enablingthe intelligent portable carrier device to communicate with commonwireless communication systems such as cellular and WiFi base stations.

An exemplary embodiment of the present invention relates to a carrierthat is primarily, but not exclusively, used as a temporary storageprocess for transporting RFID tagged sterile implants and biologicproducts or other RFID tagged biological materials that requirecontinuous monitoring during transportation.

A particular refinement of the carrier according to an exemplaryembodiment of the present invention is characterized in that the carrierprovides continuous monitoring of temperature and other environmentalfactors during transportation.

A particular refinement of the carrier according to an exemplaryembodiment of the present invention is characterized in that the carrieris light weight and strong.

A particular refinement of the carrier according to an exemplaryembodiment of the present invention is characterized in that interiorwalls of the carrier are configured to block radio frequency (RF)communications from passing into and out of the carrier.

A particular refinement of the carrier according to an exemplaryembodiment of the present invention is characterized in that the carrieris adapted to transmit data wirelessly via WiFi, Zigbee, Blue Tooth, orother known or anticipated wireless methods.

A particular refinement of the carrier according to an exemplaryembodiment of the present invention is that it is adapted to augmentknown advantages of the Smart Storage Inventory Intelligent PortableCarrier Device™ and similar processes, with products that are removedand then transported some distance through the use of a car or currier,to a point of potential use and then back again to a point of origin.For example, a point of origin could be a hospital or a clinic.

According to various embodiments, the present teachings involve methodsfor providing improved product tracking and monitoring of regulatedproducts, such as sterile implants and biological products in anintelligent portable carrier device comprising a housing, including alid-closure mechanism, the housing configured to hold the regulatedproducts. The method comprises steps of affixing a productidentification tag to at least one regulated product initialized with atleast a product ID code unique to the product type and a serial numberunique to the specific product or object; placing the at least onetagged regulated product into a carrier; placing the at least oneproduct identification reader into said carrier; scanning the productidentification tag with a scanning device to determine the product IDcode and serial number; receiving the scanned data from said scannerinto a local processor; transmitting said scanned data from said localprocessor through an electronic data network to a tracking server, andcreating a data record on said tracking server to contain said scanneddata.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects, features and advantages of the presentinvention will be apparent from a consideration of the followingDetailed Description of the invention, when considered in conjunctionwith the drawing Figures, in which:

FIGS. 1A and 1B show a front and top view, respectively, of arepresentative intelligent portable carrier device that is configuredfor RFD inventory tracking in accordance with one embodiment.

FIG. 2 is a high level block diagram depicting an illustrativeembodiment of the major functional components of an intelligent portablecarrier device in accordance with an embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description with reference to the accompanying drawings isprovided to assist in a comprehensive understanding of exemplaryembodiments of the present invention as defined by the claims and theirequivalents. It includes various specific details to assist in thatunderstanding but these are to be regarded as merely exemplary.Accordingly, those of ordinary skill in the art will recognize thatvarious changes and modifications of the embodiments described hereincan be made without departing from the scope and spirit of theinvention. In addition, descriptions of well-known functions andconstructions may be omitted for clarity and conciseness.

The terms and words used in the following description and claims are notlimited to the bibliographical meanings, but, are merely used by theinventor to enable a clear and consistent understanding of theinvention. Accordingly, it should be apparent to those skilled in theart that the following description of exemplary embodiments of thepresent invention is provided for illustration purpose only and not forthe purpose of limiting the invention as defined by the appended claimsand their equivalents.

It is to be understood that the singular forms “a,” “an,” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, reference to “a component surface” includes referenceto one or more of such surfaces.

Radio Frequency Identification (“RFID”) provides a convenient mechanismfor identifying and detecting objects using wireless electromagneticsignals. Radio frequency identification (RFID) systems typically includea transceiver and one or more transponders (RFID tags). The transceiveremits radio signals to activate the RFID tags and to read/write data tothem via an antenna. The transceiver typically has an associated decoderfor decoding data received from an RFID tag. The combination of anantenna, transceiver, and decoder is sometimes referred to as an“interrogator” in an RFID system. The transponder can be electronicallyprogrammed with any desirable information, the constraint being size. Ina typical RFID system, the interrogator transmits radio waves (rangedependent upon power and frequency). When an RFID tag enters the zone inwhich the interrogator is transmitting, it detects the decoder'sactivation signal. This causes the RFID tag to transmit its data signalback to the interrogator. RFID tags can be active (i.e., have their ownpower source for generating the data signal) or passive (i.e., useelectromagnetic energy induced in the RFID tag by receipt of theactivation signal to generate the data signal). The decoder then decodesthe data on the RFID tag. This decoded data is then typicallytransmitted to a computing system that is in communication with thedecoder. An active tag's memory size varies according to applicationrequirements; some systems operate with up to 1 MB of memory.

The RFID reader antenna generates an electromagnetic field, therebytransferring energy to the tag. Depending on the design of the tag, aportion of the energy transferred to the tag will be reflected to thereader so as to provide information about the tag back to the reader.Some RFID systems can be used to read and optionally write data to andfrom the RFID tag. RFID readers can generate signals spanning distancesfrom less than one inch to more than 100 feet depending on frequency andpower of the signals generated at the RFID reader antenna.

As is known in the art, for example from Paratore et al. U.S. Pat. No.6,294,997, herein incorporated in its entirety, by reference, RFIDdevices or tags are small, low-cost wireless transponder devicesequipped with nonvolatile memory for information storage, typicallyinformation about an item or host product to which the RFID tag isattached. For example, inventory items can carry RFID tags providinginformation such as serial numbers, price, weight, and size. RFID tagsare capable of responding to wireless interrogation by wirelesstransmission of stored information for receipt by the interrogator. Theterm “RFID tag” is used herein to include self-supporting,self-contained tags, cards or labels that are attachable to a hostproduct or product, continuous web tags separable into individual tagsfor attachment to a host product, RFIDs supported on a substrate orotherwise constructed for incorporation on or into a host product, andany other RFID device suitable for association with a host product totransmit information regarding the host product externally of theproduct.

Use of RFID tags can permit efficient retrieval of information regardingan item at various points in the manufacturing and distribution chain,and can also permit tracking of the individual item. Some RFID tagspermit relatively large amounts of data to be associated with theproduct. An RFID tag typically includes a memory, an RF transmitter, anRF receiver, an antenna, and logic for controlling the variouscomponents of the memory device. The antenna may be formed on a flexiblesubstrate, while analog RF circuits and digital logic and memorycircuits are embodied in an integrated circuit (“IC”) carried by thesubstrate and coupled to the antenna. RFID tags may also include anumber of discrete electronic components, such as capacitors,transistors, and diodes.

Passive RFID tags operate without a separate external power source andobtain operating power generated from the reader. Passive tags areconsequently typically lighter than active tags, less expensive, andoffer a long operational lifetime. Passive tags typically have shorterread ranges than active tags and require a higher-powered reader.Read-only tags are typically passive and can be programmed with a uniqueset of data (usually 32 to 128 bits) that is typically predetermined atthe time of manufacture of the tag. It is understood that passiveread/write tags can also be employed consistent with the presentteachings.

The term “RFID tag” as used herein refers to either an active or passiveRFID tag that contains information. The RFID tag can be read only orread/write, and the information associated with the RFID tag can behard-coded into the RFID tag at the time of manufacture or at some latertime, or the RFID tag can contain information that is written to theRFID tag throughout its lifetime.

The term “RFID reader” as used herein includes RFID devices that canread information from and/or write information into an RFID tag.

RFID devices or tags can take many physical forms, such as a microchip(RFID chip) from 30 to 100 microns thick and from 0.1 to 1 mm across,joined to a minute metal antenna such as the Hitachi 2.45 GHz Mew chip.Another form is the “Coil-on-Chip” system from Maxell (Tokyo, Japan).Exemplary RFID vendors of tags and/or readers and associated systemsinclude Intermec Technologies Corporation (Everett, Wash.), SymbolTechnologies (Holtsville, N.Y.), Applied Wireless Identifications, Inc.(AWID) (Monsey, N.Y.), Philips Semiconductor (Eindhoven, TheNetherlands), and Texas Instruments (Dallas, Tex.).

In general, RFID chips can include read-only devices (e.g. read-onlychips), which include a fixed electronic code. Alternatively, the RFIDchips may be read-write devices (e.g. read-write chips), which allow anupdating of prior information or an addition of new information. Thedevices may also be associated with sensors to read detected informationand transmit a signal responsive to the detected information, such as avalue detected from a biosensor. Exemplary smart tags that include. RFIDtechnology associated with a sensor are the active labels that arecommercially available from KSW MICROTEC (Dresden, Germany). Forexample, TEMPSENS active smart labels can measure and recordtemperature.

Each individual RFID reader can have an operative power supply and atleast one antenna. Optionally, the individual reader may include anantenna group or set having a plurality of antenna. Multiple antennascan, for example, help the reader interrogate and receive data from adiverse selection of tags (or other electronic data mechanisms) wherethe individual tags have been configured to operate in different,widely-spaced frequencies or frequency bands, such as low-frequency(LF), high-frequency (HF), very-high frequency (VHF), ultra-highfrequency (UHF), and super-high frequency (SHF). The operationalradio-frequency of the various components of the reader system (e.g.readers, antennas, and communication systems) can be as low as about 100KHz (kilo-Hertz), and can be up to about 6 GHz (Giga-Hertz) or more.

The reader and/or its antenna system may be powered by conventionaltechniques and devices. Such techniques and devices can, for example,include capacitors, batteries, photo-voltaic cells, electrically-wiredpower supplies or the like, as well as combinations thereof.

The systems and methods described below are directed to what has beentermed herein as RFID carrier applications; however, it will be apparentthat the systems and methods described below can be applied to anysystem in which a plurality of items being tracked or interrogated arelocated within a confined space. It will also be apparent that certainaspects of the embodiments described below are not necessarily limitedto carrier or confined space applications. Thus, it will be understoodthat the embodiments described below are by way of example only and arenot intended to limit the systems and methods described herein toparticular applications unless such a limitation is expressly indicated.

Reference will now be made in detail to some embodiments, examples ofwhich are illustrated in the accompanying drawings. Wherever possible,the same reference numbers are used throughout the drawings to refer tothe same or like parts.

FIGS. 1A and 1B show a front and top view, respectively, of arepresentative intelligent portable carrier device 100 that isconfigured for RFID inventory tracking in accordance with oneembodiment. Intelligent portable carrier device 100 can be configured totrack a plurality of stored sensitive items 103 such as tissue andbiologic products, or any other stored sensitive items. Intelligentportable carrier device 100 comprises a shell 102 with a lid-closuremechanism 104 and carrying handles 106. The intelligent portable carrierdevice 100 is shown in a closed condition in FIG. 1A and in an opencondition in FIG. 1B. The shell 102 of the intelligent portable carrierdevice 100 is constructed to completely contain any RF emitted energyduring operation and will not emit outside the intelligent portablecarrier device 100 or receive external energy that will impactoperation. The shell is preferably made of carbon fiber or other RFabsorptive, strong, lightweight materials.

It should be readily appreciated that any suitable article or othercommodity may be transported by the intelligent portable carrier device100 in addition to regulated products. For example, the selected articleor commodity may include a liquid, solid, gel, powder, food item,non-food item, compressed item or the like, as well as combinationsthereof.

FIG. 2 is a high level block diagram depicting an illustrativeembodiment of the major functional components of an intelligent portablecarrier device 100 in accordance with an embodiment of the invention. Asshown in FIG. 2, the intelligent portable carrier device 100 generallycomprises an item storage compartment 110, a battery compartment 112,and a processor compartment 114. The item storage compartment 110generally comprises one or more stored sensitive items 103, two of whichare shown by way of example, to be transported from a first location toa second location. The stored sensitive items 103 are embedded withproduct identification tags (e.g., RFID transponders or tags) 118A,118B, configured to transmit self-identifying signals. Positioned nearor within the item storage compartment 110 are antennas 105A and 105B,which may be RFID antennas, which are configured so that theirradio-frequency reception ranges (or “read zones”) encompass any RFIDtransponder or tag placed within the item storage compartment 110.Consequently, when stored sensitive items 103 are placed within the itemstorage compartment 110, antennas 105A and 105B will detect theself-identifying radio frequency signals generated by the transpondersattached to or embedded in the stored sensitive items 103.

Item storage compartment 100 also includes a temperature sensor 120(such as a thermometer), which is positioned to monitor the temperaturein the item storage compartment 110. Although FIG. 2 illustrates onlyone temperature sensor 120, it is noted that embodiments of theinvention may utilize a multiplicity of sensors for detecting variousenvironmental conditions in addition to temperature, such as, forexample, humidity, pressure and the like.

Also shown in FIG. 2 is a battery compartment 112. In variousembodiments, the battery compartment may include a power supply 126,which can utilize common power management technologies (such asreplaceable batteries, supply regulation technologies, and chargingsystem technologies) for supplying energy to the components of theintelligent portable carrier device 100 to facilitate portability. Thereis also shown an uninterruptible power supply (UPS) 128, which will beactivated whenever the intelligent portable carrier device batterysupply requires recharge while in transit. Further capabilities areprovided for connecting the carrier device 100 to an external AC powersource 130 to power the device or otherwise recharge the power supply126 and/or the uninterruptible power supply 128.

Processor compartment 114 comprises an RFD reader 136, and a number ofprocessors including an event monitor processor 138 and an event managerprocessor 140. Processor compartment 114 further comprises networkinterface. RFID Reader 136 is an event-driven RFID reader, whose primaryfunction is to collect, decode and pass on information transmitted tothe antennas 105A and 105B by the RFID transponders or tags 118A and118B attached to the one or more stored sensitive items 103. The eventmonitor processor 138 and event manager processor 140 can utilizecomputing technologies such as a microprocessor and/or digital signalprocessor (DSP) with associated storage memory such a Flash, ROM, RAM,SRAM, DRAM, or other like technologies.

RFID Reader 136 typically passes the unique identifier encoded in theself-identifying signals detected by antennas 105A and 105B to eventmonitor processor 138. Event monitor processor 138 comprises adecision-making software program or programmable logic controllerconfigured to react to the presence, absence, addition, or removal ofthe self-identifying signals from the radio-frequency reception rangesor “read zones” of the antennas tied to the RFID reader 136. Thus, insome embodiments of the present invention, event monitor processor 138will generate an event-identifying code in response to the RFID reader136 detecting that a tagged stored sensitive item is currently locatedinside or has been added to or removed from a compartment of theintelligent portable carrier device 100. Temperature sensor 120 is alsotied to event monitor processor 138 so that the event monitor processor138 can also generate a temperature change-related event code inresponse to temperature changes in the compartment.

In some embodiments of the invention, the event monitor processor 138 isalso coupled to a power fail circuit, which is configured to detect apower failure condition, such as a power outage. When this happens, theevent monitor will generate and pass to the event manager a “powerfailure” event code, which causes the event manager to determine thestarting time of the power outage, and then store the power failureevent code and the starting time of the power outage in a status log.Preferably, the system is configured to accomplish these tasks on a highpriority basis as soon as a drop in power is detected but before thepower is depleted. Alternatively, the system may be configured toaccomplish these tasks while the system is operating under the supportof an emergency temporary power source, such as a battery oruninterruptible power supply (UPS). Such an emergency power source mayalso be used by the system to power an internal clock designed to keeptrack of the current time, so long as the power failure conditionpersists.

While event monitor processor 138 determines what kind of event hasoccurred, event manager processor 140 selects the course of action totake and carries out the selected course of action. It is the eventmanager processor 140, for instance, which sounds an alarm whenever thetemperature sensor 120 detects an out of range value. The event managerprocessor 140 may in certain cases utilize network interface 146 to gainaccess to a remote inventory database (not shown in FIG. 2) via a datacommunications network 152.

Although FIG. 2 shows event monitor processor 138 and event managerprocessor 140 as two distinct components, those skilled in the computerarts will recognize that a single hardware, software or firmwarecomponent, or alternatively, a multiplicity of distinct hardware,software and firmware components, may be utilized to implement thefunctions performed by event monitor processor 138 and event managerprocessor 140, as described herein, without departing from the spirit orthe scope of the present invention.

In certain embodiments, the RFID reader 136 can be configured to receivesignals over multiple frequencies in order to increase the receptioncapabilities. For example, due to the nature of passive RFID, receptionof a tags back scatter signal on the carrier frequency can be extremelychallenging when radiating into a closed chamber. Allowing the receiverto listen on one or multiple harmonics of the carrier frequency can aidthe system's reception capability in a closed chamber environment.

It should be appreciated that the functions necessary to implement thevarious elements of the intelligent portable carrier device 100architecture may be embodied in whole or in part using hardware orsoftware, or some combination thereof using microprocessors,microcontrollers, digital signal processors, programmable logic arrays,data storage devices, embedded memory, ROM, RAM, FLASH memory, or anyother suitable types of hardware and/or software. It is furtherappreciated that although the functionality of the system architectureis illustrated in FIG. 2 as being implemented within the respectivesystem elements listed above, the system functions may alternatively beimplemented in any other suitable arrangement of elements and in anysuitable form. For example, the intelligent portable carrier devicearchitecture may include multiple instances of each type of systemelement operating in a coordinated manner to deliver the requiredapplication services.

In addition, it should be understood that the RFID reader 136 includesan RF interrogator and an RF receiver, and that the RF interrogator andthe RF receiver may reside in separate units or may be integrated into asingle device. Furthermore, when the term “reader” is employed to referto the function associated with RF tag interrogation, the term “reader”should be understood to correspond to a device that solely performs thatfunction or is integrated with a component that also performs RFreception. Similarly, when the term “reader” is employed to refer to thefunction associated with RF reception, the term “reader” should beunderstood to correspond to a device that solely performs that functionor is integrated with a component that also performs RF taginterrogation.

The location of the intelligent portable carrier device 100 may bedetermined utilizing GPS receiver 132. The GPS receiver 132 can utilizecommon technology for receiving satellite signals from a constellationof satellites to determine a location coordinate of the intelligentportable carrier device 100. Information, including locationinformation, gathered by the intelligent portable carrier device 100,may be stored in an internal memory 142 associated with processorcompartment 114 and/or transmitted, either in real-time or upon arrivalat a desired destination to a coupled device that may include, forexample, a portable computer or a main server of an existing back endinventory tracking system, such as Smart Storage™ or SAP™ where all theinformation regarding all of the intelligent portable carrier devicesbeing monitored is retained and stored. The existing back-end inventorytracking systems can be accessed by authorized individuals, hospitals,and other entities. The information pertaining to the individual carrierdevices, their contents, and locations is utilized to quickly andcorrectly augment the known advantages of existing inventory trackingsystems, such as Smart Storage™. It can also be used to stopcontaminated biologics or faulty products in-transit from beingdelivered or used by the end user.

In one embodiment, subsequent to taking an inventory of all of the itemswithin the intelligent portable carrier device 100 this information iswirelessly transmitted to a server of an existing back-end inventorytracking system via transceiver 134. The back-end inventory trackingsystem is configured to store the transmitted information. Transmissionto the server is accomplished in real-time via transceiver 134 by anywell known transmission protocol, such as for example: Wi-Fi, BlueTooth, Zigbee, COMA system with AGPS (assisted GPS), GPRS, GSM or otherknown wireless methods. The transceiver 134 can be configured to beInternet capable.

An inventory of the contents of an intelligent portable carrier device100 enables a medical representative to indicate which items have beenremoved from transport from an existing back-end inventory trackingsystem. For example, when an item, such as a biologic, is removed by amedical representative to take to a location for use, all of the producttracking and temperature monitoring is maintained by the intelligentportable carrier device 100 until it is returned to an existing back-endinventory tracking system, such as Smart Storage™ or the item isotherwise assumed used. It is also envisioned that the intelligentportable carrier device 100 can be constructed out of an insulativematerial so as to maintain a relatively standard temperature within theportable carrier device 100 relative to the atmospheric environment. Inone embodiment, the intelligent portable carrier device 100 is wrappedwith an insulative material to realize the same affect.

Such embodiments of the inventive subject matter may be referred toherein, individually and/or collectively, by the term “invention” merelyfor convenience and without intending to voluntarily limit the scope ofthis application to any single invention or inventive concept if morethan one is in fact disclosed. Thus, although specific embodiments havebeen illustrated and described herein, it should be appreciated that anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

While the invention has been shown and described with respect toparticular embodiments, it is not thus limited. Numerous modifications,changes and enhancements will now be apparent to the reader.

What is claimed is:
 1. An intelligent portable carrier device comprisinga housing including a lid-closure mechanism, a storage compartment, abattery compartment and a processor compartment, the housing beingconstructed of an RF absorptive material and configured such that any RFemitted energy within the housing does not emit outside the housing, thestorage compartment comprising a plurality of regulated productsdisposed therein, the regulated products each comprising a read-writeradio-frequency identification (RFID) tag coupled thereto, theread-write RFID tags each comprising a biosensor configured to detect acondition of the storage compartment, the device comprising a RF readerin the processor compartment configured to collect, decode and pass oninformation relating to the condition of the storage compartment basedupon signals from the tags and to detect whether each of the regulatedproducts is currently in the storage compartment or has been added to orremoved from the storage compartment based upon signals from the tags.2. The intelligent portable carrier device of claim 1, wherein theread-write RFID tags are active RFID tags that are coupled to theregulated products before the regulated products are placed inside thecarrier device.
 3. The intelligent portable carrier device of claim 1,further comprising a global positioning receiver module for receivingsignals from a global positioning system (GPS) and determining alocation of said intelligent portable carrier device.
 4. The intelligentportable carrier device of claim 1, wherein the read-write RFID tagseach include a RFID transponder that communicates with the reader andthe device further comprises: a plurality of antennas interfaced withthe reader configured to communicate radio frequency (RF) signals withthe RFID transponders; and at least one processor in communication withthe reader, configured for: i. generating event-identifying codes inresponse to detecting the presence or absence of an RFID taggedregulated product within the device; and ii. generating conditionrelated event codes in response to changes in the condition of thestorage compartment.
 5. The intelligent portable carrier device of claim1, wherein the housing comprises an insulative material configured tomaintain a relatively standard temperature within the housing relativeto an atmospheric environment.
 6. The intelligent portable carrierdevice of claim 1, wherein the read-write RFID tags are each configuredto update prior information or add new information related to anenvironmental condition within the housing.
 7. The intelligent portablecarrier device of claim 1, wherein the biosensors are configured tomeasure and record a temperature within the housing, the read-write RFIDtags each being configured to update prior information or add newinformation related the recorded temperature such that the recordedtemperature can be determined by a RFID reader.
 8. The intelligentportable carrier device of claim 1, wherein the condition is temperatureand the RF absorptive material is carbon fiber.
 9. The intelligentportable carrier device of claim 1, wherein the regulated products areselected from a group consisting of sterile implants and biologics. 10.A method for providing improved product tracking and monitoring ofregulated products, the method comprising: providing an intelligentportable carrier device comprising a housing having storage compartment,a battery compartment, a processor compartment and a lid-closuremechanism, the housing being constructed of an RF absorptive materialand configured such that any RF emitted energy within the housing doesnot emit outside the housing; affixing a radio-frequency identification(RFID) tag to at least one regulated product initialized with at least aproduct ID code unique to the product type and a serial number unique tothe at least one specific regulated product, the RFID tag comprising abiosensor configured to detect a condition of the storage compartment;placing the at least one tagged regulated product into the storagecompartment; scanning the RFID tag with a scanning device comprising aRFID reader to determine the product ID code and serial number, thescanning device being configured to determine the condition of thestorage component based upon signals from the RFID tag and to detectwhether the at least one regulated product is currently in the storagecompartment or has been added to or removed from the storage compartmentbased upon signals from the RFID tag; receiving the scanned data fromsaid scanner into a local processor, the processor positioned in theprocessor compartment; transmitting said scanned data from said localprocessor through an electronic data network to a tracking server;creating a data record on said tracking server to contain said scanneddata; providing a power fail circuit configured to detect a powerfailure condition of the device; and generating a power failure eventcode if the power fail circuit detects a power failure condition. 11.The method of claim 10, wherein the step of scanning the RFID tag with ascanning device to determine the product ID code and serial number isperformed periodically.
 12. The method of claim 10, wherein the RFIDcontinuously monitors the condition of the storage compartment.
 13. Themethod of claim 12, wherein the condition of the storage compartment istemperature.
 14. The method of claim 10, further comprising a step ofgenerating an event-identifying code in response to detecting that atagged regulated product has been added to or removed from a compartmentof the intelligent portable carrier device which houses the regulatedproducts.
 15. The method of claim 14, further comprising storing theevent-identifying code in an internal memory associated with a processorof the intelligent portable carrier device.
 16. The method of claim 10,further comprising a step of generating an environmental conditionchange related code in response to a change in the condition of thestorage compartment.
 17. The method of claim 10, wherein the step oftransmitting said scanned data from said local processor through anelectronic data network to a tracking server comprises wirelesslytransmitting said scanned data to a server of an existing back-endinventory tracking system via a transceiver of the intelligent portablecarrier device.
 18. The method of claim 10, further comprising receivingsignals from a global positioning system and determining a location ofthe intelligent portable carrier device from the received signals. 19.The method of claim 10, wherein generating the power failure event codecomprises determining a starting time of the power failure condition andthen storing the power failure event code and the starting time of thepower failure condition.
 20. An intelligent portable carrier devicecomprising a housing including a lid-closure mechanism, a storagecompartment, a battery compartment and a processor compartment, thehousing being constructed carbon fiber and is configured such that anyRF emitted energy within the housing does not emit outside the housing,the storage compartment comprising a plurality of regulated productsdisposed therein, the regulated products being selected from a groupconsisting of sterile implants and biologics, the regulated productseach comprising a read-write radio-frequency identification tag coupledthereto, the tags each comprising a biosensor configured to detect atemperature of the storage compartment, the device comprising a RFreader in the processor compartment configured to collect, decode andpass on information relating to the temperature of the storagecompartment based upon signals from the tags and to detect whether eachof the regulated products is currently in the storage compartment or hasbeen added to or removed from the storage compartment based upon signalsfrom the tags.